A London-based startup is about to trial a drug at six NHS hospitals that could stop people on cancer immunotherapy from developing a life-threatening side-effect.
Preventing Cytokine Release Syndrome
Poolbeg Pharma said its oral drug POLB 001 could make treatment for blood cancer safer by preventing cytokine release syndrome (CRS), a condition where the immune system goes into overdrive and attacks the body, leading to organ damage.
The drug could also save the NHS and other health systems millions of pounds because patients would not need to be supervised in centralized specialist cancer centres in case they succumb to a cytokine storm. Instead, care could take place in community hospitals, reducing costs per patient and allowing more patients to be treated.
Clinical Trial Details
The drug is about to be tested on 30 people who will be treated with Johnson & Johnson’s blood cancer medication teclistamab (sold as Tecvayli) at six hospitals in Britain. The trial is led by the University of Manchester and the Christie NHS Foundation Trust.
Jeremy Skillington, Poolbeg’s chief executive, said cancer immunotherapies such as CAR T-cell and bispecific antibody treatments “are working wonders, but they all have issues with this cytokine storm. So patients have to take these therapies in a dedicated cancer hospital.”
“If somebody’s living in rural UK, they’re going to have to come up to London or go to a big city … because CRS is potentially fatal. There’s no diagnostic – you can’t predict who will develop it,” he added.
About 70% of people who receive cancer immunotherapies from J&J, Gilead, Novartis, AstraZeneca and others develop CRS, which begins with fever and increased heart rate and can require intensive care. There is currently no approved therapy for CRS prevention.
In the intermediate clinical trial, patients will start taking Poolbeg’s drug at home before they begin cancer treatment “just to keep the immune system under control … and you won’t develop CRS”, Skillington said.
The drug, which was acquired from Spain’s Palau Pharma and originally developed for chronic inflammation, works by blocking a particular cell signalling pathway. Poolbeg expects to have interim data from the trial by the end of the summer.
Market Potential
Poolbeg estimates that about half a million people diagnosed with the blood cancers multiple myeloma and diffuse large B-cell lymphoma will receive immunotherapy by 2031 in the US and the five biggest European countries. Normally they have to stay in hospital for two to three weeks in case they develop CRS.
Based on a potential price of $20,000 (£15,000) per treatment with the POLB 001 drug, the market could be worth $10bn, according to Skillington, a former research scientist at the University of California who also worked at the US biotech Genentech, part of Roche. The cancer immunotherapies cost about $300,000 to $400,000 for a course of treatment.
GLP-1 Weight Loss Pill
Poolbeg is also developing a GLP-1 weight loss pill with the Irish microencapsulation company AnaBio Technologies. It will be tested in 20 healthy volunteers with a body mass index of more than 30 in an early-stage trial later this year. The trial will be led by Dr Carel Le Roux, professor of metabolic medicine at Ulster University.
Company Background
The company, named after the Poolbeg peninsula in Dublin by its co-founder, the Irish entrepreneur Cathal Friel, was spun out of the clinical research organisation hVIVO in July 2021. It listed on the London Stock Exchange’s Aim market, raising £25m to develop medicines. hVIVO, also based in Canary Wharf, traces its roots back to Retroscreen Virology, which was spun out of Queen Mary University of London in 1989 by Prof John Oxford.
Skillington said the NHS was “bursting at the seams” under cost and demand pressures. “If you can reduce that burden, that’s the ultimate goal,” he said.
